BGX COVID-19 RT-PCR Qualitative Detection Kit
BGX COVID-19 RT-PCR is a real time RT-PCR kit for qualitative detection of novel corona virus (SARS-CoV-2) nucleic acids (RNA) in human Nasopharyngeal and Oropharyngeal swab specimens. Result can be used for diagnosis of COVID-19 infection. Targets dual regions of SARS-CoV-2 nucleocapsid gene (N1 & N2) as per CDC recommendation. Internal control Primers & Probe are provided in the panel.
Ease of Operation
WARNINGS AND PRECAUTIONS:
For Use Under An Emergency Use Authorization Only For in vitro diagnostic use For Prescription Use Only
The BGX COVID-19 RT-PCR has been validated, but validation of this test has not been independently reviewed by FDA. Review under the Emergency Use Authorization (EUA) program is pending. Distributed in accordance with FDA’s guidance, “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2.” Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
A statement such as “the test has been validated but FDA’s independent review of this validation is pending,” should be included in test reports to healthcare providers.